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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 341 - Definitions and standards for food
§ 342 - Adulterated food
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 348 - Food additives
§ 355 - New drugs
§ 355a - Pediatric studies of drugs
§ 355b - Adverse-event reporting
§ 355c - Research into pediatric uses for drugs and biological products
§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
§ 355e - Pharmaceutical security
§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
§ 356a - Manufacturing changes
§ 356b - Reports of postmarketing studies
§ 356c - Discontinuance or interruption in the production of life-saving drugs
§ 357 - Qualification of drug development tools
§ 360b - New animal drugs
§ 360c - Classification of devices intended for human use
§ 360d - Performance standards
§ 360e - Premarket approval
§ 360f - Banned devices
§ 371 - Regulations and hearings
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 262 - Regulation of biological products
§ 263b - Certification of mammography facilities
Title 21 published on 19-May-2018 03:57
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 570 after this date.
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel.” This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts (“GRAS panel”) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a “GRAS panel report”), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information ( e.g., by not providing the GRAS panel with information such as trade secret information).
The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.